Trial reportDrugs in R&D2023
Pharmacokinetics and Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, Three-Period, Three-Sequence Crossover Study.
Trial report in Drugs in R&D, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04863105 (Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study
Who cites it
0 citing papers in PubMed, 0 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
Abstract
BACKGROUND AND
objectiveAbiraterone acetate tablet is an inhibitor of androgen synthesis, primarily for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This study evaluated the bioequivalence and pharmacokinetics of the reference and test formulations of abiraterone acetate tablets in healthy Chinese volunteers.
methodsA single-center, open, single-dose, randomized, three-period, three-sequence, semi-repeat (only repeated reference formulations), and reference formulation-corrected fasting reference-scaled average bioequivalence test was conducted in 36 healthy volunteers included in this study. Volunteers were randomly assigned to one of three groups in a 1:1:1 ratio. There was a minimum 7-day washout period between each dose. Blood samples were collected at prescribed time intervals, the plasma concentration of abiraterone acetate tablets was determined by liquid chromatography-tandem mass spectrometry, and adverse events were recorded.
resultsUnder fasting conditions, the maximum plasma concentration (C
conclusionBoth test and reference formulations of abiraterone acetate tablets were bioequivalent in healthy Chinese subjects under fasting conditions.
trial registrationClinicalTrials.gov identifier NCT04863105, registered 26 April 2021-retrospectively registered ( https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000ARAA&selectaction=Edit&uid=U00050YQ&ts=2&cx=-vbtjri.
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